FDA Adverse Event
Malfunction
Summary report: N
SOLETRA
MDR report key: 2061886
·
Received April 5, 2011
Report
- Report Number
- 3004209178-2011-02614
- Event Type
- Malfunction
- Date Received
- April 5, 2011
- Date of Event
- March 18, 2011
- Report Date
- March 18, 2011
- Manufacturer
- MDT PUERTO RICO OPERATIONS CO., JUNCOS
- Product Code
- MHY
- PMA / PMN Number
- P960009
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
RECEIVED INFORMATION THE PATIENT EXPERIENCED A LOSS OF THERAPEUTIC EFFECT. INTERROGATION OF THE DEVICE SHOWED IMPEDANCE READINGS OF >2000 OHMS ON ALL OR SOME OF THE UNIPOLAR PAIRS AND A READING OF <12 MICROAMPS. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED A FOLLOW UP REPORT WILL BE SENT. REFERENCE MF REPORT # 3004209178201102615 FOR RELATED INS SYSTEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SOLETRA | MHY | MDT PUERTO RICO OPERATIONS CO., JUNCOS | 7426 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | IMPLANTED:| EXTENSION: MODEL 7482, LOT# NGK015531N| IMPLANTED:| EXTENSION: MODEL 7482, LOT# NGK015531N| EXPLANTED:| IMPLANTED:| LEAD: MODEL 3387, LOT# J0206544V| IMPLANTED:| EXPLANTED:| IMPLANTABLE NEURO STIMULATOR: MODEL 7426| LOT# NFW153318H| EXPLANTED:| LEAD: MODEL 3387, LOT# J0123234V| PROGRAMMER: MODEL 7438, LOT# NHL003450P| EXPLANTED:| EXPLANTED:| IMPLANTED: |